BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3181744 · Received June 6, 2013

    Report

    Report Number
    1314492-2013-00711
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 8, 2013
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER HAS RECEIVED AND EVALUATED THE DEVICE IN QUESTION. AN UNDETECTED UPSTREAM OCCLUSION COULD NOT BE CONFIRMED AND THE DEVICE HAS FOUND TO BE WITHIN SPECIFICATION. UPSTREAM OCCLUSION AND DOWNSTREAM OCCLUSION TESTS WERE PERFORMED PER THE SPECTRUM PREVENTIVE MAINTENANCE PROCEDURE WITH THE UNIT PASSING. THE DEVICE ALSO PASSED ADDITIONAL UPSTREAM OCCLUSION TESTING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP WOULD NOT DETECT AN UPSTREAM OCCLUSION. THE DEVICE WAS RETURNED TO THE BIOMEDICAL DEPARTMENT FROM THE EMERGENCY ROOM CARE AREA. MEDICATION, PROGRAMMED AMOUNT AND DELIVERY RATE ARE UNKNOWN. NO PATIENT INJURY WAS REPORTED. THE CUSTOMER STATED THAT THE DEVICE WAS TESTED AT 100 ML/HR FOR 15 MINUTES AND THE PUMP DID NOT ALARM WHEN THE IV LINE WAS OCCLUDED. AN ADDITIONAL TEST WAS PERFORMED AT 100 ML/HR FOR 30 MINUTES WITH THE IV LINE OCCLUDED BY THE SLIDE CLAMP AND THE PUMP DID NOT ALARM FOR AN UPSTREAM OCCLUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251983 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP. 35700

    Patients

    Seq Age Sex Outcome Treatment
    1